Limb remote ischemic preconditioning for intestinal and pulmonary protection during elective open infrarenal abdominal aortic aneurysm repair: a randomized controlled trial.
Cai Li, Yun-Sheng Li, Miao Xu...
https://pubmed.ncbi.nlm.nih.gov/23353795/Actively Recruiting
Led by St. Anne's University Hospital Brno, Czech Republic · Updated on 2026-04-27
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
This research aims to evaluate the impact of obstructive sleep apnea OSA as a possible protective factor against ischemia and reperfusion IR injury during elective abdominal aortic aneurysm AAA repair and aorto-bifemoral bypass surgery. The study investigates whether patients with OSA experience less IR injury and fewer postoperative complications compared to those without OSA. The relationship between OSA severity and IR injury is also examined to understand if greater OSA severity corresponds to reduced injury. Participants scheduled for elective aorto-bifemoral bypass surgery, including those with AAA and Leriche syndrome, will be observed. Polygraphy sleep studies using the Embletta system will be conducted two nights before surgery, alongside STOP-BANG and Epworth questionnaires to assess OSA. Patients are grouped based on OSA status presence or absence and undergo the standard surgical procedure without additional interventions. During the study, markers of IR injury will be measured at multiple time points before anesthesia, and at 3, 12, 24 hours, and on the fifth postoperative day after aorta de-clamping. Cardiovascular and pulmonary complications will be monitored for 30 days after surgery. These assessments aim to track the extent of IR injury and related complications to better understand the protective role of OSA in vascular surgery. The total study period extends to 30 days post-operation with detailed outcome evaluations.
CONDITIONS
OSA as a Remote Ischemic Preconditioning in Vascular Surgery
I
Ivan Cundrle, M.D., Ph.D.
M
Marek Lukes, M.D.
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St. Anne's University Hospital Brno, Czech Republic
Lead Sponsor
Masaryk University
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 nights before surgery
Participants undergo polygraphy measurements and complete questionnaires for assessment of sleep apnea before surgery.
1 baseline visit (in-person)
Duration - Surgery day and the first 5 post-operative days
Participants undergo elective aorto-bifemoral bypass surgery followed by immediate post-operative assessments.
Multiple assessments on surgery day and 5 post-operative days
Duration - Up to 30 days post-surgery
Participants are monitored for cardiovascular and pulmonary complications for up to 30 days after surgery.
Follow-up visits as needed during 30 days
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/25281045/St. Anne's University Hospital Brno, Czech Republic
Lead Sponsor
Masaryk University
Collaborating Sponsor